BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 24151387 · Received January 22, 2026

    Report

    Report Number
    2029046-2026-00288
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    December 31, 2025
    Report Date
    January 22, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009804
    PMA / PMN Number
    P030031/S078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL SMARTTOUCH SF APPROVED UNDER P030031/S078 THE PRODUCT INVESTIGATION WAS COMPLETED BASED ON A RECEIVED VIDEO OF THE COMPLAINT DEVICE. DEVICE INVESTIGATION DETAILS: A VIDEO WAS RECEIVED FOR EVALUATION FOLLOWING JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) PROCEDURES. ACCORDING TO THE VIDEO PROVIDED BY THE CUSTOMER, DURING THE FLUSHING, THE CATHETER WAS NOT IRRIGATING CORRECTLY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE ON LOT 31709883L, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE VIDEO RECEIVED. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AND A ROOT CAUSE IS UNABLE TO BE ASSIGNED BASED ON THE CURRENT EVIDENCE. IF THE DEVICE IS RECEIVED IN THE FUTURE, THE PRODUCT INVESTIGATION WILL BE PERFORMED AND UPDATED ACCORDINGLY, AND ANY ACTION WILL BE TAKEN IF NECESSARY. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND THERE WAS AN INTERMITTENT OR LOW IRRIGATION ON THE DEVICE BUT NOT COMPLETE OCCLUSION. NONE OF THE 56 HOLES OF THE CATHETER FORMED ANY SPRAY. THE IRRIGATION ISSUE WAS NOT NOTED UNTIL THE DEVICE HAD ALREADY BEEN USED ON THE PATIENT. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO FLOW RATE CHANGE ISSUES AT THE START OF ABLATION. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215454 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31709883L 10846835009804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown